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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Robust summary alkyl sulfide catetgory CAS # 68515-88-8 Genetic Toxicity Elements: Genetic toxicity in vitro
Author:
US Environmental Protection Agency
Year:
2000
Bibliographic source:
US Environmental Protection Agency, AR201-12549bZ, 2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
In vitro gene toxicity study of Pentene, 2, 4, 4-trimethyl-, sulfurized was studied in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentene, 2,4,4-trimethyl-, sulfurized
EC Number:
271-114-8
EC Name:
Pentene, 2,4,4-trimethyl-, sulfurized
Cas Number:
68515-88-8
Molecular formula:
C24H50S8
IUPAC Name:
1-(2,4,4-trimethyl-1-{[(2,4,4-trimethylpentan-2-yl)disulfanyl]disulfanyl}pentan-2-yl)-4-(2,4,4-trimethylpentan-2-yl)tetrasulfane
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Pentene, 2,4,4-trimethyl-, sulfurized
- Molecular formula :C24H50S8
- Molecular weight: 595.144 g/mol
- Substance type:Organic
- Physical state:Liquid
Specific details on test material used for the study:
- Name of test material: Pentene, 2, 4, 4-trimethyl-, sulfurized
- EC name: Pentene, 2,4,4-trimethyl-, sulfurized
- Molecular formula: C24H50S8
- Molecular weight: 594.141 g/mole (As in Chem exper)
- Substance type: Organic
- Physical state: No data available
- Purity: 97 %
- Impurities: 3 %

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
Details on mammalian cell type (if applicable):
No aata
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
S9 microsomal fraction was isolated from Aroclor 1254-treated rat livers
Test concentrations with justification for top dose:
0, 0.01, 0.03, 0.1, 0.3 and 1 µL/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was soluble in DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-anthramine (With S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation);

DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: Three replicates

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available
Rationale for test conditions:
No data
Evaluation criteria:
The plates were observed for a dose dependent increase in the number of revertant colonies
Statistics:
The mean number of revertants/plate for three replicate assay plates was calculated for each concentration and strain.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
No data

Applicant's summary and conclusion

Conclusions:
Pentene, 2, 4, 4-trimethyl-, sulfurized is non mutagenic at a concentration of 0, 0.01, 0.03, 0.1, 0.3 and 1 µL/plate in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 and hence is negative for gene mutation in vitro.
Executive summary:

In an in-vitro gene toxicity test, Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 bacterial cells were exposed to Pentene, 2, 4, 4-trimethyl-, sulfurized in the concentration of 0, 0.01, 0.03, 0.1, 0.3 and 1 µL/plate with and without metabolic activation. Plate incorporation assay was performed with three replicate assay plates. The mean number of his- revertants/plate was calculated for each concentration and strain.The results showed that there was no significant evidence of mutation in any of the Salmonella strains in the quantitative mutagenesis assay in the presence or absence of metabolic activation. Pentene, 2, 4, 4-trimethyl-, sulfurized is non mutagenic at a concentration of 0, 0.01, 0.03, 0.1, 0.3 and 1 µL/plate in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538.